Bisphenol-A: The Role of the Citizen

U.S. Food and Drug Administration Bisphenol-A Policy

In 1976,
with the passage of the Toxic Substances Control Act (TSCA), the first U.S. law was
created to regulate industrial chemicals.This law “grandfathered” in some 62,000 chemicals, one of which was
BPA.These chemicals were presumed to be
safe by the Environmental Protection Agency (EPA) regardless of the fact that no
scientific research was undergone to assure the safety of these chemicals.This law continues to be used to this day
with only a few amendments being made in its 30-year history.Since the inception of TSCA, the U.S. EPA has
never used its authority to ban a chemical and has only formally regulated five
different chemicals.[1]

Over
thirty years after the inception of the TSCA, FDA policy regarding BPA has not
changed. Between 1982 and today, hundreds of studies have been conducted by the
government, the industry, and independent researchers with many contradictory
results.Currently, around 200 total BPA
studies have been conducted, and, out of these studies, 90% of research done
outside of the industry has found adverse effects in animals from BPA exposure
at and below current human BPA exposure levels.However, 100% of industry funded studies found no adverse effects in animals from BPA exposure at current human
exposure levels.[2]

While
the BPA research conducted over the last few decades is far from conclusive,
over the last few years, the numbers of studies showing adverse health effects
from BPA have overtaken those that give support BPA.As this research began piling up, citizen
watchdog organizations expressed outrage over the FDA’s continued support of
BPA and began voicing their concerns to citizens.Still, the most recently released FDA statement
on BPA shows no shift in federal BPA policy.On November 2, 2007, the FDA reaffirmed the safety of BPA but will
continue “actively reviewing the safety of bisphenol-A.”The FDA stated it based its most recent
stance on a recently completed review of the available data and several animal
studies. It stated its research tests
for adverse effects at all dosage levels, including very small ones, and “does not
indicate a safety concern at the current exposure level for infants or adults.”[3]

In
this most recent decision not to part with its past BPA policy, the FDA came to
its conclusions by 1) looking at its own 1990s studies that determined current
human exposure levels and then 2) compared these levels with two studies
conducted that determined the level of BPA at which adverse effects occurred in
animals.[4]There is no controversy around whether or not
BPA-laden products leach BPA – this is known to be true – ;rather, the controversy lies around the
levels at which BPA causes adverse health effects.This recent federal stance on BPA ignored
many independent scientists’ research demonstrating the levels at which BPA
causes health effects.This omission of
comprehensive research incited increased outrage and criticism in watchdog
groups and independent researchers – so much so that that Congress has been
forced to take notice.

Congress Takes Action

Beginning
January 17, 2008, the U.S. House of Representatives’ Committee on Energy and
Commerce began its inquiry into FDA bisphenol-a policy.Chairman of the committee, John D. Dingell,
began by sending letters to seven major infant formula manufacturers and to FDA
Commissioner Dr. Andrew von Eschenbach in regard to the use of BPA in products
intended for use by infants and toddlers.The infant manufacturers replied that they did not do their own testing
of BPA levels in infant formula; however, their use of BPA is in align with FDA
standards and regulations. [5]

The
FDA’s response to Rep. Dingell’s requests revealed for the first time that the
basis for its current stance is based solely on two studies both sponsored by
the American Plastics Council.[6]The American Plastics Council is a major trade association for the U.S.
plastics industry that works to promote the benefits of plastic and the
plastic industry.[7]However, the Chicago Tribune quoted deputy
director of the FDA’s office of food additive safety saying that the agency is
not biased towards industry.“The fact
is, it's industry's responsibility to demonstrate the safety of their products,"
he said. "The fact that industry generated the data to support the safety
I don't think is an unusual thing."[8]However, Frederick
vom Saal of the University
of Missouri reported in
2005 that 90% of independent studies found adverse effects in animals from BPA
at low doses while all studies funded
by the industry found no problems with BPA at current exposure levels.Furthermore, one of the two studies was not
made public, thus, it was not subject to the standard peer review process that
all studies must go through before gaining credibility and legitimacy.[9]Furthermore, restricting access to this study
leaves watchdog groups and citizens powerless to critique the science behind
the FDA’s policy.

Additionally,
one of these studies is mired in further controversy for design flaws.Brought to light by independent researchers,
one study used a special breed of rat, Sprague-Dawley, that is only responsive
to estrogen at very high doses.[10]This is significant because since BPA is a
synthetic estrogen, rats used in this study would likely be much less
responsive to or unaffected by doses of BPA that would affect humans who are
indeed sensitive to the hormone estrogen.

Science
for Sale

As
an additional part of Rep. John Dingell’s investigation, he sent a letter to
the Weinberg Group inquiring about the organization’s involvement in the BPA
debate.This company has worked on defending products
linked to health hazards such as Agent Orange, Teflon, hair-dying products, and
tobacco and describes itself as a company that it will “harness, focus, and
involve the scientific and intellectual capital of our company with one goal in
mind – creating the outcome our client desires.” However, Rep. Dingell doubts
“whether such outcomes will be congruent with the available scientific evidence.”[11]The Chicago Tribune quotes Dingell as stating,
"The tactics apparently employed by the Weinberg Group raise serious
questions about whether science is for sale at these consulting groups, and the
effect this faulty science might have on the public health."[12]Furthermore, congressional investigators say
the Weinberg Group was hired by the BPA manufacturer Sunoco.[13]Given that the FDA admits to relying on the
industry to supply the research used for policy decisions, the involvement of
the Weinberg Group in industry research is unsettling to say the least.

The Future of BPA Policy

However,
changes in the FDA’s policy on BPA could be realized in the near future.In a recent landmark decision, the U.S. National
Toxicology Program (NTP) (a subsidiary of the National Institutes of Health) released evaluations that went
against earlier findings declaring for the first time that some concern exists around effects of BPA on human development,
especially for developing fetuses, infants, and children.[14]This
April 16, 2008 decision flies in the face of current FDA policy, and Rep. John
Dingell has used the NTP’s recent conclusions to call for the FDA to change its
BPA policy.[15]In response to the NTP’s findings, scientists
and private citizens were given a chance to weight in through a public comments period.After the NTP’s initial finding, public
comments were scarce and primarily from the industry.However, as the NTP has continued to
reevaluate BPA, public comments have become much more numerous as scientists
and private citizens alike have begun weighing in on the debate and calling for
BPA policy change.[16]

[11]
Dingell, John D. "Letter to the Weinberg Group CEO Weinberg in Regard to
an Ongoing Investigation Into the Use of the Chemical Bisphenol a in Products
Intended for Use by Children." 5 Feb. 2008. Committe on Commerce and
Energy, 2008.

“I have grown up to believe that one of the roles of the federal
government is to protect its citizens and establish policies to that effect. I am disappointed and dismayed that so little
thought and oversight have been given to the scary outcomes of exposure to
bisphenol A.”